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A Comparison of Naropin and Ketorolac for Postoperative Analgesia After Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00868348
Recruitment Status : Completed
First Posted : March 25, 2009
Results First Posted : March 10, 2014
Last Update Posted : March 10, 2014
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
The purpose of this study is to determine wether ketorolac is effective in the treatment of postoperative pain after total knee arthroplasty

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Ketorolac Drug: Saline Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Local Infiltration Analgesia for Total Knee Arthroplasty: Should Ketorolac be Added
Study Start Date : May 2009
Primary Completion Date : June 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
Drug Information available for: Ketorolac
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Saline Drug: Saline
1 ml infiltration 4 ml intraarticular bolus injection of placebo
Active Comparator: Ketorolac Drug: Ketorolac
30 mg (1 ml) infiltration combined with Intraarticular bolus injection of 120 mg (4 ml) ketorolac
Other Name: Toradol

Primary Outcome Measures :
  1. Morphine Consumption [ Time Frame: 48 hours after surgery ]
    Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery

Secondary Outcome Measures :
  1. Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request [ Time Frame: within 48 hours after surgery ]
  2. Pain Intensity Scores During Walking [ Time Frame: 6-24 hours postoperatively ]
    Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)

  3. Home Readiness [ Time Frame: time to fulfilment of discharge criteria ]
    Ability to meet discharge criteria (home readiness)

  4. Length of Hospital Stay [ Time Frame: From the day of surgery until discharge ]
  5. Pain Intensity During Daily Activity [ Time Frame: 16 weeks after surgery ]
    Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Total knee arthroplasty
  • Age > 18
  • Tolerance for study drugs
  • Written informed consent

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868348

Aarhus University
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Principal Investigator: Kjels Søballe, Professor Aarhus University Hospital

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00868348     History of Changes
Other Study ID Numbers: 2008-003180-39
First Posted: March 25, 2009    Key Record Dates
Results First Posted: March 10, 2014
Last Update Posted: March 10, 2014
Last Verified: July 2013

Keywords provided by University of Aarhus:
Total Knee Arthroplasty

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action